Research ethics

Question 1

what is the Nuremberg code?

Answer 1

The voluntary consent of the human subject is absolutely essential - from Nazi experiments

Question 2

Helsinki Decleration

Answer 2

A physician shall act in the patient’s best interest when
providing medical care
Research on vulnerable only justifiable if cannot be carried out on non-vulnerable group

Question 3

Historical examples

Answer 3

Nazi experiments
U.S. Tuskegee Syphilis study; 400 men not told or treated knowing they had syphilis

Question 4

Belmont report

Answer 4

Ethical principles and guidelines for protection of human subjects research:
1. Respect
2. beneficence
3. justice

Question 5

what are the 4 ethical principles (BPS code of ethics)

Answer 5

1. respect (privacy/consent)
2. competence (skills/referral)
3. responsibility (accountability)
4. integrity (unbiased)

Question 6

what are some aspects of the BPS code of ethics?

Answer 6

Regularly reviewed as professional expectations change, encouraging recording if challenging ethical issue

Question 7

Legal obligations (BPS COE)

Answer 7

• health and care professions council (HCPC) registration
• competence
• indemnity insurance (covers negligence claims)
• equality act
• data protection (GDPR)
• freedom of information act
• health and safety at work act
• working together to safeguard children
• mental capacity act (16+)
• mental health act

Question 8

American Psych. Association: Code of conduct

Answer 8

general, aspirational guidance principles
1. beneficence and nonmaleficence
2. fidelity and responsibility
3. integrity
5. justice
6. respect for people’s right and dignity

Question 9

Human Research requirements

Answer 9

• risks explained
• participation voluntary
• valid (informed consent)
• confidentiality
• advice given (avoid potential harm)
• deception (inappropriate if leads to harm of discomfort)
  -debriefing

Question 10

what are the requirements for informed consent?

Answer 10

• full info
• voluntary
• consent involves capacity:
  > can understand relevant info & consequences and communicate decision

Question 11

What is included in ‘full info’?

Answer 11

research purpose, duration and procedure
rights to decline and withdraw
consequences of withdrawal
participation factors (risk etc.)
prospective benefits
confidentiality limits
incentives
contact for questions

Question 12

what differs in informed consent for therapeutic treatment

Answer 12

clarify experimental nature, services available, group assignment, treatment alternatives, payment

Question 13

what should be considered in high risk research

Answer 13

is it more risk than everyday, can it be reduced, is it altruistic

Question 14

IC for special groups

Answer 14

caregiver consent, risk/harm requires individuals consent plus ethics committee, child’s avoidance = withdraw

Question 15

define coercion

Answer 15

when an overt threat of harm is
intentionally presented by one
person to another in order to gain
compliance
- includes implied threat
- prohibited in Belmont report

Question 16

pros and cons to IC

Answer 16

more consideration, trust, recruitment rates /- delays, un-researchable groups, Hawthorne effect: behaviour altered when aware of being observed

Question 17

what are the requirements for inducements?

Answer 17

not excessive or coercive, alternatives (Sona) equally palatable, Belmont report prohibits undue influence

Question 18

use of deception

Answer 18

only if unavoidable as it creates distrust
- consider reaction to being misled, debrief and consult ethics committee and cultural individuals, levels of deception vary (bystander behaviour to allocation)

Question 19

filming and voice recording

Answer 19

requires consent, naturalistic studies must maintain anonymity and no potential harm (no consent needed) with respect to cultural traditions

Question 20

data confidentiality

Answer 20

GDPR or equivalent
anonymous if possible (codes/alias)
only necessary info stored
confidential unless warned otherwise

Question 21

describe debriefing

Answer 21

full explanation, avoid evaluation (self-esteem), provide contact, identified problems require referral, right to withdraw data

Question 22

internet research

Answer 22

surveys and observational studies;
public and private (personal) data
Issues:
- obtaining IC
- giving debrief
- confidentiality
- widens participation